MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK; PISTON SYRINGE

Catalog Number	UNKNOWN
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.The date received by manufacturer has been used for this field.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd syringe 10ml ll eurographics had leakage.The following information was provided by the initial reporter: propofol leaks between the sealing ring.During use propofol leaked between the sealing ring during use but did not leak further.Only as far as the middle.The customer has disposed of the packaging and does not know the lot number additional information provided: "no one got impacted".
Additional Manufacturer Narrative
(b)(4) follow up report for correction.Device was incorrect in the initial mdr.Correct device is a 20 ml syringe.Mfr report # 3003152976-2025-00527 was submitted as the site legal name was incorrectly reported as canaan in the initial mdr submission, 1213809-2025-00507.Mfr report # 3003152976-2025-00527 was submitted to update the site legal name to san agustin, and to have the proper mfr number.
Event or Problem Description
Sample received is a 20 ml syringe.

• Brand Name: BD LUER-LOK
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 22687479
• Report Number: 1213809-2025-00507
• Device Sequence Number: 9149284
• Product Code: FMF
• UDI-Device Identifier: 00382903009121
• UDI-Public: (01)00382903009121
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/01/2025
• Supplement Report FDA Received Date: 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown